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Repetitive Phrenic Nerve Stimulation in Critically Ill Patients Under Mechanical Ventilation

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Seoul National University

Status

Completed

Conditions

Electrical Stimulation
Phrenic Nerve

Treatments

Procedure: Transcutaneous, repetitive phrenic nerve electrical stimulation

Study type

Observational

Funder types

Other

Identifiers

NCT06491511
2312-166-1498

Details and patient eligibility

About

Subjects: Patients aged 19 and older who are currently in the ICU and undergoing invasive mechanical ventilation.

Methods: The study involves performing non-invasive repetitive phrenic nerve stimulation in ICU patients on mechanical ventilation.

Stimulation protocol: The intensity and position of phrenic nerve stimulation were individualized. The frequency was set to 10Hz, 15Hz, and 20Hz. The duration of stimulation was adjusted according to the set inspiration time of mechanical ventilation.

Enrollment

5 patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Adult patients aged 19 and older who are admitted to the ICU at Seoul National University Hospital
  • Patients receiving invasive mechanical ventilation (via endotracheal tube or tracheostomy)
  • Patients who have been on invasive mechanical ventilation (via endotracheal tube or tracheostomy) for more than 48 hours
  • Patients who have listened to and understood the explanation of the purpose and procedures of the study and have voluntarily agreed to participate. In cases where the patient has impaired consciousness or cognitive function and is unable to consent, the patient's legal representative has agreed to the patient's participation in the study.

Exclusion criteria

  • Patients with implanted or externally applied electrical devices (such as pacemakers, defibrillators, implantable defibrillators, vagus nerve stimulators, spinal cord stimulators, gastric stimulators, diaphragm stimulators, etc.)
  • Patients with a history of neck tumors, cervical spine instability, or neck surgery
  • Patients with internal jugular vein catheters, infections, or inflammatory signs at the electrical stimulation site, making percutaneous phrenic nerve access impossible
  • Patients with neurological or neuromuscular diseases that significantly affect respiratory muscle function
  • Patients currently receiving neuromuscular blocking agents
  • Patients already diagnosed with or suspected of having phrenic nerve paralysis
  • Patients with elevated hemidiaphragm observed on chest X-ray
  • Patients with pleural effusion occupying more than one-third of the pleural space or pneumothorax requiring chest tube insertion, as seen on chest X-ray
  • Patients who are confirmed or presumed to be pregnant
  • Patients with a body mass index (BMI) ≥ 40
  • Patients for whom life-sustaining treatment has been decided to be withdrawn and who have no plans for active treatment

Trial design

5 participants in 1 patient group

ICU patients
Description:
ICU patient with mechanical ventilator
Treatment:
Procedure: Transcutaneous, repetitive phrenic nerve electrical stimulation

Trial contacts and locations

1

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Central trial contact

Sung Eun Hyun, MD, PhD

Data sourced from clinicaltrials.gov

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